Indeed, already in place in several states are regulations covering substances in addition to those regulated by RCRA, thereby subjecting additional pharmaceuticals to heightened handling and storage requirements. Connecticut, for example, regulates many non-RCRA pharmaceutical wastes as “Connecticut Regulated Waste” (even though the state’s Department of Energy and Environmental Protection has concurrently established a stakeholder group to develop regulations to manage pharmaceutical waste in a different manner – as “universal waste”). “Connecticut Regulated Waste” is subject to the same storage requirements as RCRA hazardous waste and must be transported and disposed by state-permitted vendors.
Michigan, in contrast, regulates pharmaceutical waste as “universal waste,” which designation entails handling and disposal requirements greater than those applicable to non-hazardous solid waste but lesser than those applicable to RCRA hazardous waste. Moreover, Michigan distinguishes between various types of pharmaceutical waste (such as “bulk hazardous pharmaceutical waste” and “non-hazardous pharmaceutical waste”), each of which carries different requirements and has resulted in state regulation of more than 150 wastes in addition to RCRA-wastes. Florida, too, has a Universal Pharmaceutical Waste Rule, but the rule itself is not as straightforward as it might seem, since numerous pharmaceuticals have special exemptions and handling requirements within the state. Of course, these state-specific requirements become even more complicated when pharmaceutical waste is transported through or managed in multiple states, compounding the attention pharmacy retailers and health care facilities must pay to nuanced state regulations.
EPA has expressed that one of the goals of the current pharmaceutical waste rule-making is to promote consistency of pharmaceutical waste handling and disposal requirements. As is evident to regulators and the regulated community alike, this consistency is sorely needed. The pending proposed rule is expected to be published in December 2014 and the final rule could become effective around mid-2016. In the meantime, retail pharmacies, other healthcare facilities, and reverse distributors will have to continue working through the constantly evolving regulatory patchwork.
Ted Wolff is a partner in Manatt, Phelps & Phillips’ New York office and focuses his environmental practice on litigation and transactional work. He regularly counsels clients on compliance with environmental laws, including those that regulate the handling, storage, treatment and disposal of hazardous substances and waste. Mr. Wolff can be reached at (212) 790-4575 or twolff@manatt.com.
Matthew Dombroski is an associate with Manatt, Phelps & Phillips in New York and regularly counsels clients on environmental matters relating to corporate and regulatory compliance. Mr. Dombroski can be reached at (212) 790-4556 or mdombroski@manatt.com.
